Tests a probiotic supplement to prevent colic in healthy newborns
Tests a probiotic supplement against placebo in healthy newborns for colic.
Plain-language title generated from the registry record
Registry title: Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
Key facts
- Where
- Jette, BelgiumSee the site
Where in Belgium
- Universitair Ziekenhuis BrusselJette, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitair Ziekenhuis Brussel
- Trial code
- NCT07347743
- Record updated
- 19 February 2026
- Original description
This study aims to demonstrate that a dietary supplement, which contains two strains of the probiotic L. reuteri is safe, well tolerated and able to reduce the incidence of colic and excessive crying/fussiness in healthy infants. Additionally, the study aims to investigate if children with this probiotic supplement have better stool characteristics and a more beneficial composition of the fecal and skin flora than children given a placebo during the first 3 months of life.Read full original descriptionShow less
Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.
This study aims to demonstrate that a dietary supplement, which contains two strains of the probiotic L. reuteri is safe, well tolerated and able to reduce the incidence of colic and excessive crying/fussiness in healthy infants. Additionally, the study aims to investigate if children with this probiotic supplement have better stool characteristics and a more beneficial composition of the fecal and skin flora than children given a placebo during the first 3 months of life.
Inclusion: Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks; Infant is healthy at the time of pre-examination; Infant is aged between 1 and 14 days old at the time of inclusion; Legal guardian(s) are able and willing to follow the study instructions; Infant is suitable for participation in the study according to the investigator/ study personnel; Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3); Informed written consent given by parent / legal guardian.
Exclusion: Infant is suffering from an infection at the time of pre-examination or previous 7 days; Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease, metabolic disorder); No legal guardian's command of any local language; Infant is suffering from congenital or acquired immunodeficiency; Infant is admitted post-partum to the neonatal intensive care unit; Infant is not suitable for participation in the study according to the study personnel´s opinion.